If you are planning to submit a 510(k) for your medical device to the FDA, you should know that the FDA has tightened their expectations. Consequently, it is more important for you to become familiar with current Refuse to Accept (RTA) policy. Rather than assessing 510 (k) actual contents, the RTA’s purpose is for the FDA to quickly review your submission for completeness.

Following a checklist included in the RTA guidance document, the initial reviewer looks through your 510(k) notifying you of acceptance or rejection within 15 days of submission date. Accepted submissions move forward while rejections come with a completed check list and comments on deficiencies.

When you are formulating your submission, use the RTA checklist to your advantage filling it out referencing where you address each specific question within the 510(k). When you submit the 510(k) paperwork, include your version of the checklist.

Before you submit the 501(k), complete all your sterilization validation and electrical safety and biocompatibility testing including protocols, results and reports. Contrary to leveraging current biocompatibility data on similar materials and processes, submitters must incorporate biocompatibility testing specific to the medical device and combination of processes and materials.

To avoid resubmission, provide all performance test protocols, test data and results because the FDA no longer accepts summaries.

In their submission review, the FDA wants to make sure that you have adequately proven the safety and effectiveness of your device. To speed up device approval, use the same standards and test methods to test directly against the predicate medical device providing the FDA with very detailed information proving that your device is substantially similar to the predicate. Make sure that your device labeling for precautions, warnings, indications and contraindications matches the labeling for the predicate device.

Please contact us to learn about our expertise in recruiting for Leadership positions with emphasis in Medical Device, Biotechnology, Pharmaceutical and Health Information Sciences including Clinical, Marketing, Sales, Quality, etc. We look forward to the opportunity to help you excel in the future!

When you’re working in executive management, it can be difficult to know all of your employees personally. But if you aren’t regularly interacting with your lower-level employees, you’re missing out on benefits like employee retention, company growth, and increased productivity. Here are some ideas on how to engage with your employees:

1. Plan fun things

Everyone likes having fun, so plan some fun into your work environment. Scheduling a quarterly offsite team-building activity during a regular work day can be a great way for employees to get to know each other (and you) and feel recognized for all the hard work they do.

2. Walk around the office more

You can learn a lot about your employees and your company just by walking around the office. Observe how employees interact with each other, and pay attention to who is taking initiative regularly. For this to really be beneficial, you’ll need to start making it a habit. One walk around every few weeks isn’t going to give you a comprehensive overview of your company, but a daily walk around will.

3. Communicate regularly

Executives are often physically removed from the office, which can make it difficult to communicate regularly or effectively throughout the work week. Keep in contact with your office by communicating remotely. Share information about your business trip, or even pictures that you think your employees might appreciate, from wherever you are via email or your office’s internal messaging system.

Getting to know your employees and staying engaged with them will pay off in several ways. First, your employees will be more productive and are more likely to demonstrate initiative when they feel like their actions are noticed and will be rewarded.

In addition, getting to know your employees will give you the chance to see who is an up-and-coming executive, making it easier for you to promote from within rather than spending time and money on external hiring.

Finally, your employees are more likely to stay on your team when they enjoy their work environment, which includes feeling valued by their executive management team.

Please contact us if you are a commercial leader within a biotech or medical device company seeking your next great hire, or career advice for yourself. We look forward to the opportunity to help you excel in the future!

Running a business, team or project is hard. It’s even harder without a plan. Planning is the most important part of business. Otherwise, the business fails. Here are three questions to consider when planning for your business future.

Where Are You?

Before you can decide anything about the future of your business, you must figure out where it’s at. How can you get where you want to go if you don’t know where you’re at? You have to look at how you are doing. Are your systems working properly? Are your methods and processes up-to-date? Is your staff working with efficiency? How do you compare to other business? What are your weaknesses and what are your strengths? Is there anything that you can improve in your business? Once you figure out the answers to these questions, you can move on to the next step.

Where Do You Want to Go?

Once you figure out where you’re at as a business, you can start setting goals. Your goals should be based on your answers to the questions above. If your staff doesn’t work efficiently, you should state that you want the staff to work more efficiently. If your methods and processes aren’t up-to-date, you should fix them. If your business compares poorly to other like businesses, your goals should be to get to their level or become better than they are. Once this is figured out, you’re ready to move on to the next question.

How are you going to get there?

You know where you are, and you know where you want to go. Now you need to figure out how you’re going to accomplish your goals. If your staff isn’t working efficiently and they’re using a paper system, switch them to a paperless system. Implement updated methods and processes in your business. Find out why your competitors are doing so well and copy their habits or make them better.

Once you answer these three questions, you have made your plan. For more information, contact us.

Superbowl Sunday, the culmination of a brutal but exciting season, is quickly approaching and parties around the world are being planned. Many who watch have no idea what it really takes to become one of the teams to play in the championship game. Likewise, the public often sees only the results of the accomplishments for vital businesses. Thirty-two teams start each season hoping they will be part of the glory that stops the nation in its tracks for an evening. In reality, the process starts long before the big game in the strategy rooms of team owners, managers, and coaches.

It all starts with the draft

Every year a group of elite players are available for the NFL draft. Owners and managers come prepared with detailed research on every player that can contribute to their organization. Teams choose new players from the draft or make strategic deals with other teams for trades – all vying for the right piece of the puzzle. The draft is the first of many steps toward a championship team. Corporate leaders that build winning business teams cannot skip this step either. Those executives that do their homework and are diligent in the interview process usually have more success adding qualified candidates to their respective team.

What does it take to go to the draft with confidence? It is important to take time to research those candidates seeking to join your team, as well as understanding the role they can play. Not everyone is the quarterback, so a manager has to look at each position and see how the player works to benefit the team. Teams should have fresh eyes examine their team to see if there are individual members with overlooked talent – many times outside consultants can be used as well as 360 evaluations. Sometimes an employee who has been on the bench has matured and can become a player who can contribute in a new way.

Keep the goal in the minds of the players

Team members must have the goal in front of them at all times in order to succeed. Talent that does not have the organization’s vision in mind usually won’t grow and meet certain challenges. What happens to a talented player when he joins the team – how is he/she on-boarded? How is he inspired and made to feel part of plan and purpose of the team? A business must impart purpose to keep their talented team progressing towards the goals of the company.

Continued practice and mentoring

A team continues to prepare for the ultimate results. The tactics of opposing teams are studied in order to expose strengths and weaknesses of their competitor. Individual players should be encouraged to evaluate their performance with honesty and willingness to improve their skills. Coaches keep practice and research on the forefront even when the temptation is to let up and relax. They also evaluate their player’s entire well being to make sure they can play up to their role.

Reward

Superbowl teams have the glory of playing in front of the nation, huge financial incentives, and the coveted ring. No team can excel without appreciation and reward – they must be willing to do everything possible to obtain this goal and opportunity. The prospect of winning a world championship inspires individuals to excel to greater heights. What goals have you set for your team?

Best of luck getting the right team in place, fitting the pieces, setting the goals, and bringing it all home….

The New Year is here and with it comes fresh initiatives, new business resolutions, and innovative goals geared to take your business to the next level. Yet sometimes these goals are uninspiring in a way that doesn’t empower the company to press for even greater heights. Fear, the lack of knowledge, or sheer excuses blaming the economy can keep highly capable organizations from accomplishing amazing things…staying well below or within their potential.

When setting your goals for the New Year, commit to thinking bigger! Consider ideas that will require pushing past comfort zones yet excite your company to stretch beyond the norm. Below are three tips to help you create goals that will do just that while staying in alignment with your business objectives.

#1 Be clear on the direction of your business

Having clarity on the vision and mission of your company is perhaps the most important step in goal setting. It sets the course for everything you want to achieve in your business. This information then helps to create quantifiable targets to aim for this year.

Know where you want to go so smaller goals can be created to achieve the big-picture goal.

#2 Set specific, measurable goals

Once you are clear on your overall objective for the year, as mentioned, it’s time to break it down into small chunks and create a practical plan that shows how you will bring in your desired numbers. Be specific on what you want to achieve by each deadline. Setting quarterly deadlines that can be broken down into monthly goals, then weekly. This will better position you to excel in your goals than without having this guideline.

#3 Being committed

Goal setting and goal achievement generate two separate results. One is planning, the other is result-based. Plan your work, then work your plan. Get your team and company involved, sharing how these accomplishments will benefit the entire office. Rewarding yourselves along the way is a great way to stay motivated, especially during the challenging times.

The key is to create inspiring goals that motivate your business to dream bigger. The beauty is that even if you fail miserably, you have set a tone with your employees that you are not afraid to go for gold, encouraging them to take on this same attitude in their work and personal lives. What an incredible impact!

Please contact us here for additional assistance in meeting your recruiting and team building needs. We’d be glad to help!

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